Medicare Part D Plans Deliver Significant Savings on Innovative, Breakthrough Medicines

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Medicare Part D Plans Deliver Significant Savings on Innovative,
                       Breakthrough Medicines

Survey Finds Private Sector Negotiations Provide Both Savings and Choice,
              Making Government Interference Unnecessary
As a result of Part D, over 39 million Medicare beneficiaries now have comprehensive
prescription drug coverage. Part D enrollees are saving an average of $1,200 per year on
the cost of their medications, and over 80% are satisfied with their plan. Marketplace
competition under Part D has produced significant savings for beneficiaries and taxpayers,
as well as expanded choices for patients and their doctors. Overall, Part D savings have
been much larger than anticipated. Average beneficiary premiums dropped to $22 per
month in 2007, which is 42% below original estimates. In addition, the CMS actuary
recently projected $113 billion in Part D savings over the next 10 years, with $96 billion
directly attributable to competition leading to lower-than-expected plan bids. 1 Lower Part
D bids have largely been driven by plans’ ability to secure substantial price discounts and
rebates on drugs furnished to Medicare beneficiaries. This is the case for medicines that
treat the most common conditions afflicting the elderly population, as well as for
innovative, breakthrough therapies that target cancer and other rare and devastating
diseases. The significant discounts and beneficiary savings on innovative “single source”
Part D medicines were found in a retail price survey conducted by BIO using publicly
available information. These savings demonstrate that mandatory government
negotiation for such therapies is unnecessary, and would likely lead to reduced patient
access to current and future medical breakthroughs without providing significant savings.

Summary:

 • Part D plans negotiate significant discounts on single-source therapies. Part D
   plans were effective at negotiating discounts on the innovative, single-source
   therapies we surveyed. The average mail-order Part D prices for a broad range of
   breakthrough therapies covered by five large national prescription drug plans (PDPs)
   were found to be as much as 20% lower than drugstore.com and 17% lower than
   Costco internet mail-order cash prices. These discounts equated to average Part D
   savings of nearly $137 per therapy per month compared to drugstore.com and $142
   per therapy per month compared to Costco.

 • The Part D benefit structure provides even greater savings for Medicare
   beneficiaries at the pharmacy counter. The vast majority of beneficiaries pay
   much less than the negotiated Part D retail prices when they fill their prescriptions at
   the pharmacy. Negotiated discounts between manufacturers and Part D plans,
   combined with negotiated rebates, also translate to reduced beneficiary monthly
   premiums and cost-sharing amounts. When actual out-of-pocket spending on drugs
   covered under Part D is compared to cash prices for those drugs, beneficiary savings
   are much greater.
• Part D plans provide access to a wide array of innovative therapies. Like the
   Department of Veterans Affairs (VA) pharmacy benefit, the discount internet mail-
   order pharmacies Costco and drugstore.com limit the availability of certain
   breakthrough medicines, including several of the latest cancer therapies, which are
   widely available to Medicare beneficiaries under Part D. Marketplace competition
   under Part D provides Medicare beneficiaries with both expanded access to cutting-
   edge treatment options and significant savings.

Background:

Senators Ron Wyden and Olympia Snowe recently introduced a bill (S. 250) that would
require the federal government to negotiate directly with the manufacturers of “single
source drugs without therapeutic equivalents” covered under Part D. This category of
therapies, while accounting for only a small share of overall drug spending, includes
“first-in-class” breakthrough therapies that have become the standard of care for a variety
of rare and devastating diseases. Sens. Wyden and Snowe claim that private plans are
unable to negotiate significant price discounts on Part D drugs. 2 In a January 22 letter to
the editors of the Washington Post, Sens. Wyden and Snowe also contend that the
popular mail-order pharmacies Costco and drugstore.com offer even cheaper prices than
Part D plans “without limiting the drugs available.” 3

Previous studies have shown that Part D plans obtain average discounts of 27%, and as
high as 56%, off the cash prices of common drugs, refuting claims by Sens. Wyden and
Snowe that private plans are ineffective price negotiators. 4 To date, however,
comparative pricing analyses have focused on the drugs most commonly used by
Medicare beneficiaries. The focus on such drugs is understandable, as over 73% of
pharmaceutical spending in the 65 years and older population is concentrated in only 5
therapeutic classes in which there are a number of drugs that work in similar ways:
cardiovascular agents, antihypertensives, hormones, central nervous system agents, and
gastrointestinal agents. 5 Because S. 250 would specifically require the federal
government to negotiate on “one-of-a-kind” medicines for which there are few treatment
alternatives, BIO performed a retail price survey to assess the Part D discounts offered by
major national PDPs for a group of innovative, single-source drugs and biologics. The
purpose of this survey was to determine whether the Part D marketplace was working to
provide patient access and comparable discounts for these single-source therapies.

Methodology:

To conduct this survey, BIO selected a sample of 25 innovative drugs and biologics
eligible for coverage under Medicare Part D (Exhibit 1). In identifying the therapies to
include in our sample, we focused on oral and self-injected therapies developed by BIO
member companies that treat serious and life-threatening diseases, including cancer,
multiple sclerosis, HIV/AIDS, rheumatoid arthritis, osteoporosis, hepatitis C, chronic
kidney disease, and organ transplant rejection. The drugs and biologics in our sample

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represent some of the latest treatment breakthroughs for their respective diseases. A
number of these therapies were granted “orphan” status by the FDA because they target a
rare disease. Many of the therapies were also approved by the FDA under a “priority
review,” because the agency deemed they serve an unmet clinical need or significantly
improve upon the existing treatment options for a given disease. 6

To obtain a comparative retail benchmark, we determined the cash prices for a typical
monthly dosing regimen of each of the therapies in our sample at Costco and
drugstore.com internet mail-order pharmacies. 7 We focused our Part D price survey on
five of the top nationwide PDPs by beneficiary enrollment in 2006. 8 Using CMS’
Medicare.gov Prescription Drug Plan Finder, we obtained the negotiated mail-order
prices for the monthly drug regimens available to beneficiaries under each PDP, and then
calculated an average for each drug regimen across all five plans. The PDP prices listed
on the Medicare.gov Web site represent the negotiated prices beneficiaries would pay if
they were exposed to the full cost of their Part D drugs (i.e., when they are in the
“doughnut hole”). Since the Costco and drugstore.com prices available online are
available on internet-only mail-order prescriptions, we compared their prices to the PDP
mail-order prices, to provide an “apples-to-apples” comparison. 9 Exhibit 2 displays the
results of our survey for each of the single-source therapies we selected.

Key Findings:

The negotiated Part D prices for all of the single-source therapies in our survey were
lower than the cash prices available through Costco and drugstore.com. The Part D
negotiated prices for the innovative drugs in our sample were on average 11.6% lower
than Costco prices and 10.5% lower than drugstore.com prices. The dollar amounts
associated with these savings were also quite substantial, averaging $141.75 and $136.93
per therapy per month compared to Costco and drugstore.com, respectively. The savings
available through the lowest Part D negotiated drug prices from among the five plans
were as high as 23% compared to Costco and 26% compared to drugstore.com for
individual therapies. In addition, a comparison between the cash prices charged by
national chain retail pharmacies in three states, California, Missouri, and Florida, and the
negotiated retail prices available under the PDPs included in our survey revealed even
greater savings under Part D, averaging 17% across the innovative therapies in our
sample. These results confirm that Part D plans are able to effectively negotiate
discounts with manufacturers for innovative, single-source therapies. The discounts
obtained for our survey of innovative therapies were comparable to the substantial Part D
savings for more commonly prescribed brand-name drugs reported in prior studies.

The actual savings to Medicare beneficiaries are much greater than those reflected
in the negotiated Part D retail and mail-order prices. The savings reported in Exhibit
2 are based on comparisons between the full negotiated Part D mail-order list prices and
the discount cash prices charged by Costco and drugstore.com. Also not reflected in

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negotiated Part D list prices are the rebates plans receive from manufacturers, which are
an important contributor to the lower-than-expected premiums and costs of Part D
coverage. In addition, Medicare beneficiaries filling their Part D prescriptions at the
pharmacy are exposed to a far lesser share of their drugs costs because of cost-sharing. It
is only when enrollees must satisfy a plan deductible or enter the “doughnut hole” that
they are exposed to the full Part D negotiated drug prices. However, a 2006 study by
PricewaterhouseCoopers found that only 8% of all Medicare beneficiaries are affected by
the “doughnut hole.” 10 In addition, in 2007, beneficiaries had more opportunities to enroll
in plans that provided gap coverage.

Certain single-source therapies from our sample were not available through either
Costco or drugstore.com, and were also left off the VA national formulary. Contrary
to the previous statements made by Sens. Snowe and Wyden in their January 22
Washington Post letter to the editor, this analysis found that the Costco and
drugstore.com internet mail-order pharmacies do limit the drugs they make available to
customers. For example, neither drugstore.com nor Costco offered three of the latest,
targeted cancer treatments, Sutent, Nexavar, and Sprycel, which were all found on every
PDP formulary we examined. These and other therapies we analyzed were also not
available under the VA national formulary (Exhibit 1), which is used by the VA to secure
additional discounts from manufacturers. Studies have shown that the VA national
formulary restricts access to some of the latest, cutting-edge treatments, including many
single-source drugs and biologics.

Conclusion:

The findings from this survey highlight the effectiveness of the competitive forces
operating under Part D to achieve enhanced patient access to new and innovative
medicines while containing costs for beneficiaries and taxpayers. Contrary to claims
made by proponents of direct government negotiation under Part D, a comparison
between the prices available under the top PDPs and those available through discount
mail-order pharmacies Costco and drugstore.com reveal that private plans are able to
negotiate significant discounts for innovative therapies. Part D plans also secure
additional rebates from manufacturers that are not reflected in the negotiated retail and
mail-order list prices for drugs, but rather, are passed on to beneficiaries in the form of
lower monthly premiums and reduced cost-sharing amounts. Unlike the VA and the
internet-only discount pharmacies we surveyed, in addition to savings, Part D provides
beneficiaries with expanded access to many of the latest medical breakthroughs,
including those targeting cancer. Thus, proposals that call for mandatory government
interference in determining prices for drugs covered under Part D, such as S. 250, will
only undermine the current success of the program, and harm seniors’ access to
innovative medicines.

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Exhibit 1: Sample of Single-Source Part D Therapies

          Innovative, Single-Source Drugs and Biologics Included in the Survey, with VA
                          Formulary Status and Additional Information

                                                                                                                On VA
                                                                                                                              Additional
Medication                          Indication                                                                 National
                                                                                                                               Notes*
                                                                                                             Formulary? 11
Tarceva (erlotinib)                 Non-small cell lung and pancreatic cancer                                     No             PR
                                    Chronic myeloid leukemia (CML) and gastrointestinal stromal tumor          Yes (with
Gleevec (imatinib)                                                                                                              PR, O
                                    (GIST)                                                                    restrictions)
                                    Advanced renal cell carcinoma (RCC) and gastrointestinal stromal
Sutent (sunitinib)                                                                                                No             PR
                                    tumor (GIST)
                                    Chronic, accelerated, or myeloid or lymphoid blast phase CML with
Sprycel (dasatinib)                 resistance or intolerance to prior therapy; Philadelphia chromosome-          No            PR, O
                                    positive acute lymphoblastic leukemia with resistance to prior therapy
Nexavar (sorafenib)                 Advanced renal cell carcinoma (RCC)                                           No            PR, O

Revlimid (lenalidomide)             Multiple myeloma and deletion 5q myelodysplastic syndromes (MDS)              No            PR, O
                                    Postmenopausal women with hormone receptor positive early breast
Femara (letrozole)                                                                                                No             PR
                                    cancer
Targretin (bexarotene)              Cutaneous manifestations of cutaneous T-cell lymphoma                         No            PR, O

Thalomid (thalidomide)              Multiple myeloma and erythema nodosum leprosum (ENL)                          No            PR, O
                                    Postmenopausal women with estrogen receptor positive early breast
Aromasin (exemestane)                                                                                             No              O
                                    cancer
                                    Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis;
Enbrel (etanercept)                                                                                               No
                                    psoriasis
Humira (adalimumab)                 Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis             No

Raptiva (efalizumab)                Chronic moderate to severe plaque psoriasis                                   No
                                    Secondary hyperparathyroidism in patients with chronic kidney disease
Sensipar (cinacalcet HCL)           (CKD) on dialysis; hypercalcemia in patients with parathyroid                 No            PR, O
                                    carcinoma
Renagel (sevelamer HCL)             Control of serum phosphorus in patients with CKD on hemodialysis              Yes

Avonex (Interferon beta -1a)        Relapsing forms of multiple sclerosis                                         Yes

Betaseron (Interferon beta-1b)      Relapsing forms of multiple sclerosis                                         Yes

Copaxone (glatiramer acetate)       Relapsing-remitting multiple sclerosis                                        Yes
                                    Postmenopausal women with osteoporosis who are at high risk for
Forteo (teriparatide)                                                                                             No
                                    fracture
Pegasys (peginterferon alfa 2a)     Chronic hepatitis C virus infection                                           Yes
CellCept (mycophenolate             Prophylaxis of organ rejection in patients receiving allogeneic renal,
                                                                                                                  Yes            PR
mofetil)                            cardiac or hepatic transplants
                                    Prophylaxis of organ rejection in patients receiving allogeneic liver,
Prograf (tacrolimus)                                                                                              Yes           PR, O
                                    kidney, or heart transplants
                                    Prophylaxis of organ rejection in patients aged 13 years or older
Rapamune (sirolimus)                                                                                              Yes            PR
                                    receiving renal transplants

Fuzeon (enfuvirtide)                HIV-1 infection in combination with other antiretroviral medications          Yes            PR

                                                                                                               Yes (with
Reyataz (atazanavir sulfate)        HIV-1 infection in combination with other antiretroviral agents                              PR
                                                                                                              restrictions)
                                             *PR=Priority Review Status; O=Orphan Drug Status

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Exhibit 2: PDP Negotiated Mail-Order Savings

           Average Price Discounts on Innovative Therapies under Part D Compared to Cash
                   Prices Listed at Costco and drugstore.com Internet Pharmacies*

                                                                          Compared to                  Compared to
                                                                             Costco                   drugstore.com
Medication                             Strength       Quantity
                                                                                     Dollar                       Dollar
                                                                    % Savings                   % Savings
                                                                                    Savings                      Savings
Tarceva (erlotinib)                     150 mg        30 tablets      -9%           $265.84      -16%            $541.81
Gleevec (imatinib)                      100 mg        30 tablets      -5%            $33.45      -12%             $91.03
Sutent (sunitinib)                       50 mg       30 capsules      Not Available at Costco   Not Available at drugstore.com

Sprycel (dasatinib)                      70 mg        60 tablets      Not Available at Costco   Not Available at drugstore.com

Nexavar (sorafenib)                     200 mg       120 tablets      Not Available at Costco   Not Available at drugstore.com

Revlimid (lenalidomide)                  10 mg        30 tablets      Not Available at Costco   Not Available at drugstore.com

Femara (letrozole)                      2.5 mg        30 tablets      -8%            $19.19       -5%             $11.09
Targretin (bexarotene)                   75 mg       100 capsules    -12%           $285.43       -6%            $126.95
Thalomid (thalidomide)                  200 mg       28 capsules      Not Available at Costco   Not Available at drugstore.com

Aromasin (exemestane)                    25 mg       30 capsules     -15%            $41.98       -9%             $21.78
Enbrel (etanercept)                    50 mg inj.      4 vials       -13%           $192.11      -11%            $157.10
Humira (adalimumab)                    40 mg inj.      2 vials       -13%           $180.11      -11%            $157.10
Raptiva (efalizumab)                    125 mg         4 vials        Not Available at Costco   Not Available at drugstore.com

Sensipar (cinacalcet HCL)                30 mg        30 tablets     -17%            $57.38      -14%             $43.87
Renagel (sevelamer HCL)                 800 mg       180 tablets     -13%            $39.83       -9%             $25.43
Avonex (Interferon beta -1a)          30 mcg inj.      4 vials       -12%           $195.41       -3%             $38.62
Betaseron (Interferon beta-1b)         0.3 mg inj.     15 vials      -14%           $253.48      -10%            $175.47
Copaxone (glatiramer acetate)          20 mg. inj      30 vials       -9%           $144.00       -9%            $140.98
Forteo (teriparatide)                 750 mg inj.     3 mL pen        -9%            $63.23      -20%            $154.93
Pegasys (peginterferon alfa 2a)        180 μg inj.     4 vials        -7%           $110.04      -11%            $195.54
CellCept (mycophenolate mofetil)        500 mg       100 tablets     -14%            $84.13       -5%             $29.92
Prograf (tacrolimus)                     5 mg        100 capsules    -12%           $244.39      -17%            $373.14
Rapamune (sirolimus)                     1 mg        100 tablets     -16%           $131.29       -6%             $43.88
Fuzeon (enfuvirtide)                   90 mg inj.      60 vials      -12%           $257.13     Not Available at drugstore.com

Reyataz (atazanavir sulfate)            150 mg       60 capsules     -11%            $94.76      -15%            $136.02
                        Average Savings Per Therapy Per Month:      -11.6%          $141.75     -10.5%           $136.93

       *
        Part D plans achieve additional savings from negotiated rebates, leading to lower premiums and
       lower costs of coverage. These additional savings are not included in the table.

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1
  Centers for Medicare and Medicaid Services (CMS), Press Release, “Medicare Drug Plans Strong and
Growing,” January 30, 2007.
2
  Letter to HHS Secretary Michael Leavitt from Sens. Olympia Snowe and Ron Wyden, December 6, 2006.
3
  Letter to the Editors of the Washington Post from Sens. Olympia Snowe and Ron Wyden, “Negotiating
Medicare Drug Prices Would Help,” January 22, 2007.
4
  Centers for Medicare and Medicaid Services (CMS), Updated Report, “Medicare Drug Coverage Provides
Significant Price Discounts and Savings,” September 20, 2006.
5
  Stagnitti, M.N., “The Top Five Therapeutic Classes of Outpatient Prescription Drugs Ranked by Total
Expense for the Medicare Population Age 65 and Older in the U.S. Civilian Noninstitutionalized
Population, 2004.” Statistical Brief #153. December 2006. Agency for Healthcare Research and Quality,
available at: http://www.meps.ahrq.gov/mepsweb/data_files/publications/st153/stat153.pdf.
6
  Food and Drug Administration (FDA), “Fast Track, Accelerated Approval and Priority Review,”
available at: http://www.fda.gov/oashi/fast.html (accessed January 2007).
7
  If a drug was not listed the Costco or drugstore.com Web sites, BIO placed phone calls to the pharmacy to
determine whether the product was available for purchase. In some instances, this resulted in receiving the
Costco and drugstore.com pricing data over the phone. We acknowledge that certain products may be in
limited distribution due to safety issues.
8
  The PDPs (and sponsors) included the following: AARP Medicare Rx Plan (UHC-PacifiCare), Humana
PDP Standard (Humana), Wellcare Signature (Wellcare), Medicare Rx Rewards Value (WellPoint), and
YOURx Plan (Medco).
9
  For comparative purposes, PDP mail-order prices displayed on the Medicare.gov Plan Finder tool reflect
the full cost of drugs on a monthly basis. Most Part D plans require enrollees to obtain a 90-day supply in
order to use the mail-order option.
10
   PricewaterhouseCoopers, “Significance of the Coverage Gap Under Part D,” June 8, 2006.
11
   Department of Veterans Affairs, VA National Formulary, December 2006, available at:
http://www.pbm.va.gov/NationalFormulary.aspx.

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